Imatinib Mesylate in Treating Patients With Advanced Cancer and Liver Dysfunction

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Phase I trial to study the effectiveness of imatinib mesylate in treating patients who have advanced cancer and liver dysfunction

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Imatinib Mesylate

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed surgically incurable solid tumor orhematologic malignancy for which no standard or palliative therapy exists oris no longer effective

• All tumor types are eligible, including:

• Chronic myelogenous leukemia or other Philadelphia chromosome-positive leukemia OR

• Gastrointestinal stromal tumors

• Patients with gliomas that require corticosteroids or anticonvulsants must beon a stable dose and seizure-free for 1 month

• No unstable or untreated (non-irradiated) brain metastases

• Performance status - ECOG 0-2

• Performance status - Karnofsky 60-100%

• More than 3 months

• WBC at least 3,000/mm^3

• Absolute neutrophil count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

• No active hemolysis

• See Surgery

• No evidence of biliary sepsis

• Creatinine normal

• Creatinine clearance at least 60 mL/min

• No symptomatic congestive heart failure

• No unstable angina pectoris

• No cardiac arrhythmia

• Able to swallow pills

• No other uncontrolled concurrent illness that would preclude study participation

• No ongoing or active infection

• No uncontrolled diarrhea

• No psychiatric illness or social situation that would preclude study compliance

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective barrier contraception during and for 6 months after study completion

• At least 24 hours since prior colony-stimulating factors

• No concurrent colony-stimulating factors

• At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered

• See Disease Characteristics

• See Disease Characteristics

• At least 4 weeks since prior radiotherapy and recovered

• See Disease Characteristics

• At least 10 days since prior placement of shunt for treatment of biliary obstruction

• At least 14 days since prior major surgery

• No prior solid organ transplantation

• No other concurrent investigational agents

• No concurrent therapeutic doses of warfarin for anticoagulation

• No other concurrent investigational or commercial agents or therapies for treatment of this disease

• No concurrent combination antiretroviral therapy for HIV-positive patients

• No concurrent acetaminophen of more than 4,000 mg/day